This invention relates to a new and safe pharmaceutical composition for treating of infertilities and increasing immune function.
Specifically, this invention provides a new and safe composition, which is Icariin extracted from Epimedium sagittatum Maxim, E. brevicornum Maxim and E. macranthum Morr. The chemical structure of Icariin is indicated.
The development of plant drug has progressed very successfully now. Taxol, for example, is a novel anticancer plant drug isolated from the needles and bark of the western yew, Taxus brevifolia. It is the prototype for a new class of anti-tumor drugs, which are characterized by their capacity to promote the assembly of microtubules. In tissue culture, taxol is a potent inhibitor of cell replication in the G or M phase of the cell cycle. Cytoplasmic microtubules in these drug-related cells are resistant to disassembly. In addition, these cells display an unusual inter-phase microtubule cytoskeleton consisting of free and bundled microtubules and lose their ability to migrate.
Clinical studies have demonstrated taxol to have antitumor activity indlude against advanced ovarian and breast cancer. Recent clinical trials have shown that paclitaxel and docetaxel may also be useful agents for the treatment of non-small-cell lung cancer, head and neck cancer, and other types of cancer.
The promising clinical activities of the anticancer taxol combined with potential problems due to limited supply generated a multitude of programs worldwide, such as broader clinical trials and in-depth clinical evaluation of anticancer taxol, efforts to provide an adequate supply of paclitaxel for clinical trials and for cancer patients, development of better drug formulations, biochemical studies to elucidate the precise mechanism of action, chemical studies to obtain structure activity information, development of second-generation paclitaxel analogues, elaboration of semisynthetic methods for the large scale production of the anticancer taxol, and efforts directed at the total synthesis of paclitaxel. Example of taxol indicated that pure natural medicine is very important. More important is in August 2000, FDA issued the draft version of xe2x80x9cGuidance for Industry Botanical Drug Products (xe2x80x9cGuidancexe2x80x9d), which explains when a botanical drug may be marketed under an OTC drug monograph and when FDA approval of a NDA is required for marketing. It strongly shows the commitments of FDA to further open U.S. market to qualified botanical drugs. Many new regulatory approaches to access the safety and effectiveness of botanical drugs are recommended in the Guidance as follow, which differentiate botanical drugs from synthetic or highly purified drugs and hence remove some long-standing technical obstacles for the ultimate approval of FDA to admit qualified botanical drugs as new drugs in the U.S. The present invention relates to a new natural pharmaceutical composition comprising specific ingredients Icariin (ICN), which is extracted from Epimedium sagittatum Maxim, E. brevicornum Maxim and E. macranthum Morr. ICN, which is contrary to Taxol, does not have problems due to limited supply. The source of Morinda officinalis How is very plenty. In traditional Chinese medicine, it is mainly the dried root of Epimedium sagittatum Maxim, E. brevicornum Maxim and E. macranthum Morr. It has traditional used for treatment of impotence; cold pain of the lower abdomen; arthralgia due to wind, cold, beriberi, pain of loin and knee.
Epimedium sagittatum Maxim, E. brevicornum Maxim and E. macranthum Morr. are Chinese medical plants. However, according to traditional Chinese medical way, the whole plants or leaves, roots and fruit of plants were put into a bowl of water boiling nearby, then patients drank above liquid. This way, obviously, cannot be industrialize. In this invention, Epimedium sagittatum Maxim, E. brevicornum Maxim and E. macranthum Morr were extracted by plant biochemistry and obtained active ingredient. Further, the chemical structure of ingredient has been indicated.
So far, there are no any articles or patents reported that a safe pharmaceutical compound which is an extract of Epimedium sagittatum Maxim, E. brevicornum Maxim and E. macranthum Morr. were used for treating infertilities and increasing immune function.
The herbs named xe2x80x9cEpimedium sagittatum Maxim, E. brevicornum Maxim and E. macranthum Morr.xe2x80x9d, has been recorded the treatment of sexual impotency by using alcohol extract of Morinda officinalis How and achyranthus L.
According to this invention, ICN is an efficient extract of possessing the effects of treating infertility and increasing immune function.
The sperm quality of the people has an obvious declining tendency in modern society. The average sperm volume ejaculated is 2.75 ml at present in comparison with 3.4 ml in 1940""s. The average sperm concentration (density) has dropped from 113 to 66 million/ml. The average total amount of sperm ejaculated has been decreased by 53% in comparison with that in 1950""s. In accordance with the report by Family Planning Technical Direction Station, male patients with infertility have occupied 21% among the whole male population. Up to now, there is no single effective drug of plant extract used for the treatment of male infertility.